Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study

Primary Effectiveness Endpoint: A clinically significant reduction in GERD symptoms,
specifically "Troublesome" regurgitation with or without heartburn assessed by the Reflux
Disease Questionnaire (RDQ).

Troublesome symptoms are those which occur a minimum of 2 days a week and are at least
moderate in severity.

Secondary Effectiveness Endpoint: The normalization of esophageal acid exposure at 6 months
and a clinically significant reduction in PPI usage at 12 months.

Inclusion Criteria:

- Age 18-80 years

- Dependent upon daily PPIs for > 6 months

- Troublesome symptoms, specifically heartburn or regurgitation, while on 40 mg of
omeprazole or equivalent.

Troublesome heartburn or regurgitation symptoms are those which occur a minimum of 2-3 days
a week and are at least moderate in severity.

- Abnormal ambulatory pH study off PPI therapy for 7 days.

- Normal or near normal esophageal motility (by manometry)

- Hiatal hernia axial height is no larger than 2 cm and the transverse dimension should
not exceed 2.5 cm

- Patient willing to cooperate with post-operative dietary recommendations and
assessment tests

- Signed informed consent

Exclusion Criteria:

- BMI > 35

- Hiatal hernia > 2 cm

- Esophagitis Los Angeles grade C or D

- Esophageal ulcer

- Esophageal stricture

- Esophageal motility disorder

- Pregnancy or plans for pregnancy in the next 12 months (in females)

- Immunosuppression

- ASA > 2

- Portal hypertension and/or varices

- History of previous resective gastric or esophageal surgery, cervical spine fusion,
Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or
dermatomyositis, eosinophilic esophagitis, or cirrhosis

- Active gastro-duodenal ulcer disease

- Gastric outlet obstruction or stenosis

- Severe gastroparesis or delayed gastric emptying confirmed by solid-phase gastric
emptying study if patient complains of postprandial satiety during assessment

- Coagulation disorders

- Interprocedural determination of anatomical presentation which in the opinion of the
surgeon does not allow safe device introduction.